Submission Details
| 510(k) Number | K833688 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 31, 1983 |
| Decision Date | May 31, 1984 |
| Days to Decision | 213 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
K833688 is an FDA 510(k) clearance for the SUTURE REMOVAL KITS STERILE, a Tape And Bandage, Adhesive (Class I — General Controls, product code KGX), submitted by Carwild Corp. (Walker, US). The FDA issued a Cleared decision on May 31, 1984, 213 days after receiving the submission on October 31, 1983. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5240.
| 510(k) Number | K833688 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 31, 1983 |
| Decision Date | May 31, 1984 |
| Days to Decision | 213 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | KGX — Tape And Bandage, Adhesive |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 880.5240 |